Since the highly-anticipated release of USP <800> there has been much discussion among healthcare pharmacies about the interpretation of these new guidelines---and what that will mean for their operations once implementation takes full effect later this year. During this workshop participants will examine the new standards and discover practical applications.

This workshop will offer CEs.

Key items addressed include:

Facility design

Creating an OSHA compliant HD List

Shipping HDs

OSHA Hazardous Communications Programs

Respiratory protection

Workflow considerations

Personnel training

Primary Engineering Controls (PECs)

Deactivation and decontamination

In addition, USP <797> has issued a revised draft.We will cover key differences that are critical to your practice including:

Changes to how BUDs (Beyond-Use Dates) may be assigned

Testing requirements

Revised facility requirements

Gowning and garbing requirements

Learning Objectives:

Define what is considered a hazardous drug

Provide strategies to achieve USP <800> compliance

Review proposed changes to USP <797>

Intended Audience:

This workshop is relevant to sterile and non-sterile compounders.

Your Instructor(s):

Jon Pritchett, Pharm.D.,RPh.Associate Director, Pharmacy

Bryan Prince, MBACompounding Safety, Workflow, and Design Consultant

L.R. Dillon, RPh.ASQ CMQ/OE, ASQ CQA, ACHC/PCAB CAC, ASQ SSGB, HDDP

USP <800> Compliance Workshop Agenda - (8:00am - 4:30pm)

Registration / Continental Breakfast

Introductions/Agenda/PCAB Update

Intro to USP <800> – Protection Not New

How To Read SDS/HD List/What Should be on the List

Break

The Environment – Sterile and Non-Sterile

Lunch / Questions

Decontamination

PPE

Personnel

Receiving and Shipping

OSHA Communication Plan

HD Waste

Break

USP <797> Update

Wrap-up / Questions

Jon Pritchett, Pharm.D.,RPh.Associate Director, Pharmacy

Dr. Jon Pritchett serves as Associate Director, Pharmacy. He has a diverse pharmacy background, most recently as Pharmacy Manager of a PCAB-accredited compounding pharmacy. During this time, he specialized in sterile and non-sterile compounding, and focused on men’s health and veterinary medicine. Jon earned his Doctor of Pharmacy (PharmD) from Campbell University College of Pharmacy & Health Sciences, and is a Registered Pharmacist in the state of North Carolina.

Bryan Prince, MBACompounding Safety, Workflow, and Design Consultant

Bryan Prince, MBA, is the owner and lead consultant at Lab·Red Pharmacy Consultants (His early career in containment technology allowed him access to pharmaceutical labs throughout the U.S., where he gleaned extensive knowledge of chemical handling technique and safety strategies. In 2012 he started visiting compounding pharmacies to observe workflow habits and share his knowledge, which led to writing articles for the International Journal of Pharmaceutical Compounding (IJPC). Bryan has been invited to speak at conferences on compounding workflow and USP <800> for the ACA, IACP, ACHC, PCCA, and Fagron.

L.R. Dillon, RPh.ASQ CMQ/OE, ASQ CQA, ACHC/PCAB CAC, ASQ SSGB, HDDP

Rad is an American Society for Quality (ASQ) Certified Manager of Quality and Organizational Excellence and an ASQ Certified Quality Auditor, and is also an ASQ Certified Six Sigma Green Belt. Rad is a Certified Accreditation Consultant for ACHC/PCAB. In the last five years, he has averaged one ACHC/PCAB surveying or consulting assignment per week involving hazardous drugs. He is the primary author of the PCAB Standard Operating Procedures for Non-Sterile & Sterile Compounding sold by ACHC/PCAB. He is also the informal chairperson for the Hazardous Drug, Nonsterile Compounding and Sterile Compounding Consensus Groups.